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PubMed2001

Acceptability of the Reality female condom and a latex prototype.

We report on the comparative acceptability of a prototype latex female condom and the polyurethane Reality female condom. We also identified factors associated with acceptability, measured via a composite index with domains related to ease of insertion, noise, and comfort during insertion and use. There were 135 couples in this randomized crossover trial. The average age was 30 years; more than 60% had education beyond high school; 40% were married; and participants were at low risk for sexually transmitted disease and pregnancy (due to the investigational status of the prototype). Participants were asked to use three of each of the study condoms during a 6-week period. Acceptability ratings on 12 items were summed into a composite index for each participant by condom type. The index midpoint (range) for females was 48 (12-84), and it was 32 (8-56) for males, with lower scores indicating higher acceptability (men completed only a subset of the acceptability questions). Both condoms were equally acceptable: Mean scores were 37 and 40 for the women's ranking of the prototype and Reality, respectively (P =.07) and 29 and 30 for men's rankings, respectively (P =.35). Multiple regression models to predict acceptability scores by gender were somewhat uninformative (most R(2) values were less than 0.10). Nevertheless, minority ethnicity (African American or Hispanic vs. white) was associated with higher acceptability by both genders for both condom types. Among women, for both condom types, less education (less than high school compared with high school or beyond) was associated with higher acceptability. Female condom acceptability may not be equally distributed across demographic groups, which is important for health educators to keep in mind when promoting the female condom.

Adolescent↗
PubMed1998

User acceptability of a female condom (Reality) in Shanghai.

Thirty married couples evaluated the Reality female condom on questionnaires about its acceptability for 300 acts of coitus (10 per couple). An analysis of the summary questionnaires showed: 90% of couples considered the female condom an acceptable method and 87% felt it was a good contraceptive device; the majority of couples (87%) found it easy to use; and 80% of females and 73% of males reported that, in comparison with the male condom, the effect on sexual pleasure was either improved or no different. A little more than half of the couples (55%) preferred it to male condoms. To look at the learning curve effect, an additional analysis was completed by pooling the first 5 applications of each user and comparing the results with the pooled results of the second 5 uses. All the findings suggest that a certain proportion of couples of childbearing age will choose the Reality female condom for contraception if it enters into the Chinese market. As a new contraceptive barrier device, the female condom may require a certain amount of education and awareness before it will be fully recognized as an important option to help prevent pregnancy as well as sexually transmitted infections.

Adult↗
PubMed2001

Structural integrity of the female condom after multiple uses, washing, drying, and re-lubrication.

Establishing the safety of re-using the female condom could significantly increase women's access to barrier methods especially in poorer countries. In this study, the structural integrity of female condoms was tested (n = 295) after multiple acts of vaginal intercourse. Fifty women were recruited to the study. Each woman re-used one condom up to eight times and washed, dried, and re-lubricated between each use. Structural integrity was measured using standard quality control testing; water-leakage, air-burst, and seam tensile strength. All results were compared to the United States Food and Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all cycles were above the FDA minimum standards for seam strength and burst tests. There was no deterioration detected in condoms used 8 times when compared to new female condoms in these tests. Five holes were detected by the water leakage test across all cycles, of which three were detected by the subjects themselves and reported to the investigators, therefore, giving a breakage rate of 1.7%. The holes were not associated with increased number of uses. This study provides further evidence that suggests the structural integrity of the female condom after multiple use is still within FDA minimum standards, although random holes resulting from handling occur infrequently with the re-use procedure.

Coitus↗
PubMed2006

A review of female-condom effectiveness: patterns of use and impact on protected sex acts and STI incidence.

We conducted a systematic review of 137 articles and abstracts related to various aspects of the female condom, as well as a closer analysis of five randomized controlled trials on effectiveness. These five studies indicated strongly the benefits of female-condom use in increasing protected sex acts, and two studies found promising decreases in sexually transmitted infection (STI) incidence with the introduction of the female condom. Ten studies provided detailed information on patterns of long-term use, many suggesting that the female condom reaches women less likely to use other dual protection methods. There exists limited but convincing evidence that the female condom is effective in increasing protected sex and decreasing STI incidence among women. Future research on the female condom must move away from assessing acceptability and focus on assessing effectiveness and improving impact in diverse settings.

Clinical Trials as Topic↗
PubMed1998

Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial.

BACKGROUND: The male condom is the most effective barrier method available for protection against sexually transmitted diseases (STDs), including HIV infection. There is an urgent need to develop and evaluate other prevention methods, such as the female condom. This study estimated the additional protection against STDs offered to sex workers by giving them the option of using the female condom when clients refused to use a male condom. METHODS: Sex establishments in four cities in Thailand were randomized into two study groups: one in which sex workers were instructed to use male condoms consistently (male condom group); and one in which sex workers had the option of using the female condom if clients refused or were not able to use male condoms (male/female condom group). Randomization was done by sex establishments, and not by individuals, to minimize sharing of female condoms across study groups. The proportion of unprotected sexual acts (defined as sexual acts in which condoms were not used, tore, or slipped in or out) and incidence rate of STDs (gonorrhoea, chlamydial infection, trichomoniasis and genital ulcer disease) were measured over a 24-week period and compared between the two study groups. FINDINGS: Results are available from 34 sex establishments (249 women) in the male/female condom group, and 37 sex establishments (255 women) in the male condom group. Condom use was very high in both groups (97.9 and 97.3 % of all sexual acts, respectively, P > 0.05). Male condom use was lower in the male/female condom group when compared with the male condom group (88.2 and 97.5%, respectively, P < 0.001). However, this reduction in male condom use was counterbalanced by the use of female condoms in 12.0% of all sexual acts in the male/female condom group, contributing to a 17% reduction in the proportion of unprotected sexual acts in this group when compared to the male condom group (5.9 versus 7.1%, respectively, P = 0.16). Female condom use was sustained over the entire study period. There was also a 24% reduction in the weighted geometric mean incidence rate of STDs in the sex establishments of the male/female condom group compared to the male condom group (2.81 versus 3.69 per 100 person-weeks, P = 0.18).

Adolescent↗
PubMed2000

Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics.

OBJECTIVES: This study evaluated a behavioral intervention designed to promote female condoms and reduce unprotected sex among women at high risk for acquiring sexually transmitted diseases (STDs). METHODS: The effect of the intervention on barrier use was evaluated with a pretest-posttest design with 1159 female STD clinic patients. RESULTS: Among participants with follow-up data, 79% used the female condom at least once and often multiple times. More than one third of those who completed the study used female condoms throughout follow-up. Use of barrier protection increased significantly after the intervention, and high use was maintained during a 6-month follow-up. To account for attrition, the use of protection by all subjects was projected under 3 conservative assumptions. The initial visit and termination visit projections suggest that use increased sharply after the intervention and declined during follow-up but remained elevated compared with the baseline. CONCLUSIONS: Many clients of public STD clinics will try, and some will continue, to use female condoms when they are promoted positively and when women are trained to use them correctly and to promote them to their partners. A behavioral intervention that promotes both female and male condoms can increase barrier use.

Adolescent↗
PubMed2004

Introducing and negotiating the use of female condoms in sexual relationships: qualitative interviews with women attending a family planning clinic.

Safe sex skills training often teach women to be assertive in condom use negotiations. However, it has been suggested that assertiveness training may be inappropriate for women who lack power in their sexual relationship. Our qualitative study of 62 women attending a family planning clinic explored various communication styles they used to introduce and negotiate female condom use in their sexual relationships. We further examined how different introduction and negotiation styles were related to actual use of the device. The device was introduced using a direct, semidirect, indirect, or nonverbal communication approach. Use of the female condom was negotiated by avoiding sex, using humor, discussing the possibility of using the condom, or being argumentative with partners. The outcome of introducing and negotiating female condom use was often mediated by other factors including partner characteristics, relationship power dynamics, situational context, and use of additional discourse strategies (e.g., describing the female condom as a sexual toy or taking the opportunity to educated partners about the female condom). Less direct approaches appeared to be as effective in facilitating use of the female condom as more direct approaches. Female condom introduction and negotiation styles that continued to engage their partners by using additional discourse strategies led to more frequent use of the device. Implications of our findings for HIV risk reduction program development are discussed.

Adult↗
PubMed1995

The female condom (Femidom)--a study of user acceptability.

OBJECTIVE: To determine the acceptability of the female condom (Femidom). DESIGN: Questionnaire survey following the use of the Femidom during sexual intercourse. SETTING: Groote Schuur and Somerset Hospitals, Cape Town. PARTICIPANTS: Nurses, secretaries, doctors and domestic staff of Groote Schuur and Somerset Hospitals who volunteered-61 women were recruited, 8 did not use any female condoms, and 1 did not return. Many women refused, mainly because of the unaesthetic appearance of the Femidom and the fact that they had to continue using their regular contraceptive and they did not think their partners would co-operate. OUTCOME MEASURES: Sexual responsivity compared with that without Femidom; acceptability of the method; women's and their partners' enjoyment of using the method; comparison with the male condom; awareness of HIV-AIDS and protective measures that can be used. RESULTS: Of the 52 participants, 23 used all 10 Femidoms issued to them. Thirteen women and 18 of their partners did not enjoy using the method and 9 had problems with it. Sex with the Femidom was the same or better in 51.9%. The Femidom was unacceptable in 32.7%, acceptable in 52% and very acceptable in 13.4%. Compared with the male condom, 50% of women and 44.2% of men considered the Femidom as good or better. Of the 61 women, 59 had heard of AIDS, and awareness of protective measures was good. CONCLUSION: There was resistance to accepting the Femidom, mainly because of its unaesthetic appearance and because women were participating for altruistic reasons. Acceptance and ease of application improved with use. Comments regarding problems and subjects' and their partners' enjoyment varied from extremely positive to extremely negative; 65.4% considered sex using the Femidom acceptable or very acceptable. It is important to inform and obtain co-operation from the male partner. The female condom has been developed as an alternative for women to use if their partners refuse or dislike using male condoms. Perfect use of the Femidom may reduce the annual risk of acquiring HIV by more than 90% in women who are sexually active with an infected male. The efficacy of the female condom has been described as equal to that of the diaphragm. The Femidom will increase the range of choices of contraceptives and prophylactic methods available for protective sex. It should become accepted as a method of contraception and an adjunct to other contraceptive methods as a prophylactic against sexually transmitted diseases and AIDS, particularly in relationships that are not mutually monogamous.

Adult↗
PubMedDate not supplied

Comparative contraceptive efficacy of the female condom and other barrier methods.

Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.

Clinical Trials as Topic↗
PubMed2000

Structural integrity of the female condom after a single use, washing, and disinfection.

The Reality(R) female condom is approved for use during a single act of intercourse, but is expensive relative to other barrier methods. Re-use is a potential strategy to reduce its per-use cost. We tested the structural integrity of female condoms (n = 318) after a single act of vaginal intercourse. We also measured the impact of laboratory washing (1, 5, or 10 times) with and without disinfection on the structural integrity of unused condoms. Structural integrity was measured via 5 tests: seam tensile strength, water leakage, air-burst, tear propagation, and device dimensions. No degradation in device structural integrity occurred after a single use when compared to control for seam tensile (16.0 vs.15.7 mPa; p = 0.558); water leakage (1.9% vs. 0.9%; p = 0.618); air burst (3.9 vs. 3.6 kPa; p <0.001); or tear propagation (344.6 vs. 336.8 psi; p = 0.313). Mean length was slightly increased [single use vs. control (177.9 vs. 172.5 mm; p <0.001)]. No consistent pattern of structural degradation emerged across all wash/disinfection groups. Our data suggest the structural integrity of the female condom remains intact after a single use and cleaning.

Coitus↗
PubMed1993

Commentary: the new female condom--item 1 on a women's AIDS prevention agenda.

A US Food and Drug Administration (FDA) advisory panel has recommended that the female condom Reality be approved for contraception and acquired immunodeficiency syndrome (AIDS) prevention. Final FDA approval will mark the first official recognition of a woman-controlled method for protection against sexually transmitted disease. A female condom allows women to use just one method to respond to the twin anxieties of AIDS and unwanted pregnancy. In those couples in which the man refuses to wear a male condom, the availability of a female condom makes protection possible for the first time. Although the female condom has some advantages over the male condom--greater comfort for some women and men and nonreliance on male arousal--general population experience with the device is needed to achieve regular widespread use and hence effectiveness at population levels. The FDA still lags behind in responding to women's needs for information on AIDS and sexually transmitted disease.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Acceptance and use of the female condom among women with incomplete abortion in rural Tanzania.

BACKGROUND: This study describes the outcome of a postabortion care intervention aimed at introducing the female condom as a means of preventing women from having unwanted pregnancies and sexually transmitted infections (STIs)/HIV. METHODS: Postabortion contraceptive counseling and services were offered to 548 women admitted to the Kagera Regional Hospital for incomplete abortion. The counseling included information about STI/HIV and the use male or female condom. In total, 521 (95%) women accepted contraception. RESULTS: Contraceptive use was assessed 3 months after abortion among 475 (91%) women. The female condom was accepted by 201 of 521 (39%) and was used by 158 of 521 (30%). Women who had experienced an unsafe abortion, had attended secondary school or earned an income were more likely to accept the female condom. The women were generally satisfied with the method, and the majority intended to use it again. CONCLUSION: Postabortion care programs provide an excellent entry point for introducing the female condom as a contraceptive method for the prevention of both repeat unwanted pregnancies and STI/HIV infection.

Abortion, Induced↗
PubMed1999

The acceptability of the female condom among substance-using women in Washington, DC.

This research is based on structured interviews, semi-structured interviews, and informal firsthand observation of women residents of Washington, DC who used crack and/or injected drugs during the previous 30 days. The study entailed introducing these women to the female condom, exposing them to an HIV risk reduction intervention teaching them how to use it and how to negotiate its use with their sexual partner(s). Women were tested for HIV and asked to return one week later for their results. They were asked to try the female condom within that first week. Upon returning for their tests results, ethnographers discussed with them their experiences with the female condom. They were reinterviewed for follow-up three months later to assess changes in behavior from baseline as well as their longer term experiences with and opinions of the female condom. The data presented in this paper are based on the interviews conducted one week after baseline. Of particular interest and concern to this research were: women's perceptions of the female condom prior to and subsequent to using it, women's partners' perceptions of the female condom after being introduced to it, and potential barriers to use. In all, 131 women, mostly African-American, took part in this study, which was conducted during the winter of 1997-1998.

Adult↗
PubMed1997

[Dynamics of female condom acceptability among prostitutes and young women in Abidjan, Ivory Coast].

OBJECTIVE: To assess the acceptability of the female condom among 2 groups of women in Côte d'Ivoire. DESIGN: Trial of use. SETTING: Abidjan, non-medical structures. PARTICIPANTS: 114 women accepted initial interview: 52 commercial sex workers (CSWs), 62 young women. 103 women volunteered for the trial of use. INTERVENTIONS: 20 female condoms given to the CSWs, 10 given to the young women; adapted instructions for use, counselling on AIDS, STDs and genital anatomy provided before and all along the trial. MAIN OUTCOME MEASURES: Qualitative assessment with some quantitative measures. RESULTS: The female condom aroused a general interest from all participants. 90% accepted to use it; 75% of 103 volunteers completed the trial. Approximately 1,200 utilizations were recorded. Prevalence of misuses was low (approx. 2% of the total); prevalence of discomforts was much higher. All the users except two wanted to use it in the future. CONCLUSION: Safe protection and dual protection (against HIV/STDs, pregnancies) were the two main sources of interest; CSWs quickly appropriated this new tool. Considering these data, the HIV infection rate among young women in Côte d'Ivoire, and evidence of changing attitudes towards birth spacing, a low-price distribution programme of female condoms for all women is recommended, with an educational component and the community participation.

Adult↗
PubMedDate not supplied

Factors associated with use of the female condom.

Black, Hispanic and white women recruited for an HIV prevention intervention were instructed in the use of the female condom and encouraged to try the device. Of the 231 women who completed the intervention, 29% tried the condom over the course of a month; 30% of those who tried it used it during at least half of their sexual encounters. Both ethnicity and age were associated with trying the device: Nearly 40% of black women and 30% of Hispanic women did so, compared with 18% of white women; 37% of those aged 25-34 tried the female condom, compared with 22% of women younger than 25. Trying the device was more likely among women living with a partner, those with a history of sexually transmitted disease infection, women who had had an HIV test, those who did not believe that the method afforded them a greater degree of overall control than did the male condom and those who had no prior knowledge of the device. Among women who used the device during at least half of their sexual encounters, 27% were black and 44% were Hispanic: 38% were younger than 25, and 43% were single. More regular users were about half as likely as less regular users to experience difficulty with insertion and one-eighth as likely to report the device slipping during use; they were more likely than less regular users to report that sex was more pleasurable with the female condom than with the male condom.

Adolescent↗
PubMed2002

Effect of an STD/HIV behavioral intervention on women's use of the female condom.

OBJECTIVES: This study assessed the effectiveness of a sexually transmitted disease (STD)/HIV behavior change intervention in increasing women's use of the female condom. METHODS: A total of 604 women at high risk for STDs and HIV in New York City, Baltimore, Md, and Seattle, Wash, enrolled in a randomized controlled trial of a small-group, skills-training intervention that included information and skills training in the use of the female condom. RESULTS: In a logistic regression, the strongest predictors of use were exposure to the intervention (odds ratio [OR] = 5.5; 95% confidence interval [CI] = 2.8, 10.7), intention to use the female condom in the future (OR = 4.5; 95% CI = 2.4, 8.5), having asked a partner to use a condom in the past 30 days (OR = 2.3; 95% CI = 1.3, 3.9), and confidence in asking a partner to use a condom (OR = 1.9; 95% CI = 1.1, 3.5). CONCLUSIONS: Clinicians counseling women in the use of the female condom need to provide information, demonstrate its correct use with their clients, and provide an opportunity for their clients to practice skills themselves.

Adolescent↗
PubMed2001

The female condom, a tool for empowering sexually active urban adolescent women.

Adolescent women are at high risk of sexually transmitted diseases/human immunodeficiency virus (STDs/HIV) because of physiologic susceptibility and risky sexual behavior. The latter may be related to the "personal factors" of self-efficacy, sexual knowledge, self-esteem, and ability to communicate/negotiate. In the current study, near-peers attempted to have an impact on these factors by using the female condom as a negotiating tool for safer sex in a group of 100 urban adolescent women recruited from an adolescent health center waiting room. This pilot study consisted of a questionnaire, a workshop on how to use the female condom and negotiate its use, and follow-up interviews at 1 and 4 months. Demographics of the study sample define a multiethnic (40% black, 33% Hispanic) group in late adolescence (average age 18 years) completing high school. At baseline, 18% evidenced depression, 62% had moderate-to-low self-esteem, 91% had an internal locus of control. At baseline, male condom use in the prior 6 months was 28% always, 51% inconsistently, 21% never. When baseline and follow-up scores were compared, there was a statistically significant increase in sexual knowledge and self-efficacy, together with the suggestion of improved negotiating skills. At 1 month, 50% (20/40) had tried the female condom, and 17 of these women planned to use it in the future. Total percentage of protected sex acts increased significantly during the follow-up period through increased use of both the male and female condoms. The data suggest that adolescent women will accept the female condom and can be empowered to protect themselves from STDs/HIV through its application or through the using of it as a negotiating tool.

Adolescent↗
PubMed1999

Facilitators and barriers to use of the female condom: qualitative interviews with women of diverse ethnicity.

Women in the United States, particularly African-Americans and Hispanics, are at increased risk for HIV. The female condom now offers women a potentially important option for HIV prevention, yet few efforts have been made to increase its use. To elucidate strategies to promote the use of the female condom, we conducted in-depth interviews with 62 women recruited from the four major racial/ethnic groups of the U.S. (African-American, Asian-American, Hispanic, and white). Subject recruitment took place at a family planning clinic in San Francisco during 1996-97. We identified four major types of facilitators and barriers to use of the female condom: mechanical, psychosexual, interpersonal, and situational. Specifically, the mechanical facilitators and barriers included positive and negative aspects of the device, and difficulty with insertion. The psychosexual factors were female empowerment, more options for contraception and disease prevention, discomfort with vaginal insertion, and condom use norms. The interpersonal factors included: enhanced communication, relationship status, partner preferences, and partner objections. Finally, the situations that made women disinclined to use the device were: no access to the female condom when having sex and using other forms of contraceptives. The implications of these findings for HIV prevention and future research are discussed.

Adolescent↗